跳至主要内容
临床试验/NCT06732128
NCT06732128招募中不适用

Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease: a Pilot Randomized Controlled Trial

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Tolerability of nature-based virtual reality

研究概览

简要总结

Behavioural and psychological symptoms of dementia (BPSD), such as depression affect up to 90% patients with dementia. Non-pharmacological treatment of BPSD, can be difficult to access, require caregiver support, travel, and often have long waiting lists. Virtual reality (VR) is an innovative, portable, immersive, and accessible technology which can be used in-home. More information is required on the feasibility of using VR in-home with older adults with dementia.

Our study will offer a 4-week program of 15-minutes sessions, twice per week nature-based VR program for BPSD delivered in-home by virtual reality (VR). Additionally, caregivers will have the option of taking part in the study and provide feedback regarding the VR intervention. If successful, this project has the potential to prolong aging in place for individuals with BPSD, as BPSD is a significant factor in institutionalization.

详细描述

The burden of dementia is rapidly growing, affecting nearly 50 million individuals globally and costing $818 billion dollars yearly. Alzheimer's disease (AD) is the most common form of dementia. AD includes changes in mood and behavior, referred to as the behavioral and psychological symptoms of dementia (BPSD). Depression is among the most common BPSD, impacting 50% of older adults with AD. Existing pharmacological treatment for depressive symptoms in AD (AD-D) lack evidence for efficacy and have many potential side effects (e.g. cognitive impairments, falls, mortality), Non-pharmacological interventions have been recommended but are associated with significant challenges such as travel, cost and the difficulty in accessing specialized therapists.

Virtual reality (VR), an immersive audiovisual technology, can address these challenges as it is an accessible and cost-effective intervention which can be delivered in a variety of settings. VR can easily be delivered in-home, and therefore address many of the limitations of traditionally delivered non-pharmacological interventions, such as accessibility, intervention non-adherence and difficulties with maintaining intervention frequency. Additional technology will be utilized to collect physiological data such as movement using the Fitbit Charge 6 and a Muse headband will measure electroencephalogram (EEG). Previous literature on VR based intervention for older adults is limited, with very few randomized control trials, rather it is primarily case studies, cross-sectional studies, and non-immersive VR. However, there are no studies assessing in-home VR for individuals with AD or for AD-D.

We propose a pilot randomized controlled trial (RCT) to assess nature-based VR intervention (N-VR) for AD-D. We will randomize (1:1) 50 participants with AD-D to N-VR vs. an active control intervention of various nature-based videos (N-CI). All participants will receive the intervention as 15-min sessions delivered twice a week, assessor-blinded, for 4 weeks. Assessments will be conducted at baseline, within 7 days of starting the intervention, at follow-up, within 7 days of completing the 4-week course, and after each 15-min session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of mild to early-moderate stage AD (including mixed dementia with AD) using the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. Criteria
  • Age of 50 years or older
  • Medical stability to participate in the trial
  • Patient Health Questionnaire score 5-14
  • Investigator judgement on whether the participant is comfortable with technology
  • Access to WiFi and a smart device for connecting on WebEx and downloading the Fitbit and Muse applications
  • Have someone available to be present during all sessions

排除标准

  • Unstable medical or psychiatric condition, including substance use based on an investigator opinion
  • Visual or hearing impairments that would impair participation
  • Patient Health Questionnaire score 15-27 and/or score of 1 or 2 in section E question 1 of the Cornell Scale for Depression in Dementia
  • Any other reason, which will make the study participation intolerable for the participant in the opinion of the study investigator

结局指标

主要结局

Tolerability of nature-based virtual reality

时间窗: 4 weeks

Hypothesis 1a (Tolerability): Using the Simulator Sickness Questionnaire (SSQ) at the end of the last session, the mean SSQ score for N-VR group will be less than 10 (with 10 or more being the cut-off for clinically significant cybersickness)

Feasibility of nature-based virtual reality

时间窗: 4 weeks

The number of sessions completed and major/minor technical issues during the session.

Acceptability of nature-based virtual reality

时间窗: 4 weeks

The Personal Involvement Inventory (PII) score mean after the last N-VR completed session.

次要结局

  • Depression in AD-D(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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